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NCT00104104 · OUTCOME

Time to First Significant Increase in Serum Creatinine

A Multiple Myeloma Trial in Patients With Bone Metastases · Source last updated 2011-06-29

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
weeks
Interval / dispersion
Full Range
Time frame
Up to 24 months

What was measured

Median time to event in participants who had a clinically relevant increase in serum creatinine.

Analysis population: Safety Population; enrolled patients who received at least one dose of study medication. The medians shown are only for patients who had a significant increase by 24 months.

Groups in this outcome

15 - Minute Infusion

Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.

30 - Minute Infusion

Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
15 - Minute Infusion24
30 - Minute Infusion23

Reported measurements

Source class 1
Values in weeks · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
15 - Minute Infusion21.619.884.165.0Not reported
30 - Minute Infusion24.431.482.693.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.1
        spread
        19.88
        upper Limit
        65.0
        value
        21.6
      2. group Id
        OG001
        lower Limit
        2.6
        spread
        31.48
        upper Limit
        93.9
        value
        24.4
denoms
  1. counts
    1. group Id
      OG000
      value
      24
    2. group Id
      OG001
      value
      23
    units
    Participants
description
Median time to event in participants who had a clinically relevant increase in serum creatinine.
dispersion Type
Full Range
groups
  1. description
    Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
    id
    OG000
    title
    15 - Minute Infusion
  2. description
    Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
    id
    OG001
    title
    30 - Minute Infusion
param Type
MEDIAN
population Description
Safety Population; enrolled patients who received at least one dose of study medication. The medians shown are only for patients who had a significant increase by 24 months.
reporting Status
POSTED
time Frame
Up to 24 months
title
Time to First Significant Increase in Serum Creatinine
type
SECONDARY
unit Of Measure
weeks

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice